NeuRx Diaphragm Pacing System — Class III medical device recall Z-1393-2022
Terminated recall by Synapse Biomedical Inc, reported 2022-07-27, distributed in AL, CA, CO, FL, GA, IL, MA, MI…. Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to
| Recall number | Z-1393-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synapse Biomedical Inc, Oberlin, OH, United States |
| Recall initiated | 2022-05-31 |
| Classified | 2022-07-18 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2024-04-11 |
| Distributed | AL, CA, CO, FL, GA, IL, MA, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SC, TX, WV |
| Quantity | 71 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00852184003007, 00852184003038, 00852184003045, 00852184003052, 00852184003090, 00852184003106, 00852184003113, 00852184003120, 00852184003137, 00852184003144, 00852184003151, 00852184003168, 00852184003175, 00852184003182, 00852184003267, 00852184003281 |
| Serial numbers | 20-0028-031022-5, 20-0028-060221-5, 20-0028-062421-5, 20-0028-062521-5, 20-0028-072821-5, 20-0035-010722-5-4, 20-0035-010722-5-5, 20-0035-030722-2-2, 20-0035-031122-5-1, 20-0035-031122-5-2, 20-0035-031122-5-5, 20-0035-033122-5-1, 20-0035-033122-5-2, 20-0035-033122-5-3, 20-0035-040622-4-1, 20-0035-040622-4-2, 20-0035-040622-4-3, 20-0035-042122-1-1, 20-0035-113021-3-3, 20-0035-120221-2-1, 20-0035-121621-5-2, 20-0035-121621-5-3, 20-0040-010622-10, 20-0040-012221-10, 20-0040-012621-10 and 12 more |
Product
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006
Reason for recall
Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1393-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.